Actively Recruiting
An Open-Label, Exploratory, Phase 2 Scintigraphy Study Evaluating 18F-mFBG for Imaging Myocardial Sympathetic Innervation in Subjects With and Without Lewy Body Diseases
Led by Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) · Updated on 2026-03-27
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating 18F-meta-fluorobenzylguanidine (18F-mFBG), a new imaging agent, to measure the effect of neurodegenerative diseases like Parkinson's disease and Lewy body dementia on heart nerve function. This Phase 2 study compares 18F-mFBG imaging results in patients with Lewy body disease to those with other neurological disorders and historical healthy controls. The aim is to improve understanding of how these diseases impact the heart's sympathetic nervous system using advanced PET imaging. All participants receive an intravenous injection of 222-370 MBq (6-10 mCi) of 18F-mFBG. Imaging is done twice: a whole-body scan from head to pelvis at 30 minutes post-injection, followed by a detailed static image of the chest at 60 minutes. The study includes two groups—those with Lewy body disease and those with other neurological diseases—both undergoing the same procedures. Participants will have their heart nerve imaging results analyzed quantitatively to assess the extent of nerve damage. Researchers will also measure whole-body distribution of the tracer and compare uptake between groups. The study includes assessments at 6 months to evaluate imaging accuracy and reproducibility. Safety and stability of participants are monitored, and participation duration varies with study procedures.
CONDITIONS
Brief Title
18F-mFBG Cardiac Uptake With Lewy Body Dementia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age at study entry
- Able and willing to follow study procedures and provide signed informed consent
- Male or female who is surgically sterile, postmenopausal, non-lactating, or of childbearing potential with a negative pregnancy test
- Clinically stable for at least 30 days before enrollment and remains stable until imaging
- For Lewy body disease group: diagnosed with Parkinson's disease or Lewy body dementia at least 6 months prior
- For non-Lewy body disease group: diagnosed with a neurological disease other than Parkinson's disease or Lewy body dementia by a neurologist
You will not qualify if you...
- Previously participated in this study or any other investigational drug or device study within 30 days
- History or suspicion of severe allergic reaction to 18F-mFBG components
- Any serious, active, life-threatening disease with life expectancy under 1 year or that may interfere with study participation
- Documented ischemic heart disease or heart failure
- Serious non-cardiac medical condition causing high plasma catecholamines, including pheochromocytoma
- Claustrophobia or movement disorder preventing lying still on back for up to 20 minutes
- Renal insufficiency with serum creatinine above 3.0 mg/dL
- Use of medications interfering with uptake of norepinephrine transporter agents that cannot be withheld safely
- Participation in studies involving ionizing radiation within the past 12 months that could exceed 50 milliSieverts total dose during that time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive an intravenous injection of 18F-mFBG followed by whole-body PET imaging to assess myocardial sympathetic innervation and whole-body activity distribution.
1 imaging visit (in-person)
Duration - 6 months
Participants are monitored for up to 6 months to assess quantitative imaging outcomes and disease progression.
Follow-up assessments as scheduled
Trial Site Locations
Total: 1 location
1
Houston Methodist Neurological Institute
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
R
Research Coordinator
C
Clinical Trials Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here